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Using 22C3 Anti-PD-L1 Antibody Concentrate on Biopsy and Cytology Samples from Non-small Cell Lung Cancer Patients
Published on: September 25, 2018
Neoadjuvant anti-programmed death-1 immunotherapy by pembrolizumab in resectable non-small cell lung cancer: First
Florian Eichhorn1, Laura V Klotz1, Mark Kriegsmann2
1Department of Thoracic Surgery, Thoraxklinik, University Hospital Heidelberg, Heidelberg, Germany; Translational Lung Research Center (TLRC) Heidelberg, Member of the German Center for Lung Research (DZL), Germany.
Objectives:
A phase II trial investigating the therapeutic effect of neoadjuvant programmed cell death 1 (PD-1) inhibitor pembrolizumab (MK-3475, KEYTRUDA®) administered prior to surgery for the treatment of non-small cell lung cancer (NSCLC) has been conducted (NCT03197467). We report the first clinical results of a planned interim safety analysis after 15 patients were enrolled.
Material And Methods:
Patients with resectable NSCLC stage II/IIIA were included. Two cycles of pembrolizumab (200 mg intravenously once every 3 weeks) were administered prior to surgery. The primary objectives were to assess the feasibility and safety of neoadjuvant pembrolizumab therapy and to evaluate antitumor activity. We analyzed the clinical parameters as well as pathological and radiological tumor response data.
Results:
The NSCLC histology was adenocarcinoma for 13 patients and squamous cell carcinoma for 2 patients. All patients but two underwent 2 cycles of pembrolizumab prior to surgery. Four patients (27 %) presented a major pathologic response. Significant tumor target response in positron emission tomography computed tomography (PET-CT) was detected in all 4 pathologic responders. Nevertheless, the PET findings mismatched the tumor load in some patients. A PD-L1 expression ≥10 % in the pretreatment biopsy was associated with at least major pathologic response. Five patients (33 %) presented grade 2-3 treatment related adverse events (TRAE), the overall postoperative morbidity was 7 % and 30-day mortality was 0 %.
Conclusion:
Neoadjuvant pembrolizumab is a feasible therapy in surgical lung cancer patients. It was associated with tolerable toxicity and did not compromise tumor resection.
Insights
Neoadjuvant pembrolizumab is a safe and feasible treatment for resectable non-small cell lung cancer (NSCLC) before surgery. This approach showed tolerable toxicity and did not hinder tumor resection in early trial results.
Area of Science:
- Oncology
- Immunotherapy
- Thoracic Surgery
Background:
- Non-small cell lung cancer (NSCLC) remains a leading cause of cancer mortality.
- Neoadjuvant therapy aims to improve surgical outcomes and treat micrometastatic disease.
- Programmed cell death 1 (PD-1) inhibitors offer a novel immunotherapeutic approach.
Purpose of the Study:
- To evaluate the feasibility and safety of neoadjuvant pembrolizumab in resectable NSCLC.
- To assess the antitumor activity of pembrolizumab prior to surgery.
- To analyze clinical, pathological, and radiological response to neoadjuvant therapy.
Main Methods:
- A phase II clinical trial (NCT03197467) enrolled 15 patients with resectable NSCLC (Stage II/IIIA).
- Two cycles of pembrolizumab (200 mg IV every 3 weeks) were administered before surgical resection.
- Feasibility, safety, and antitumor response (pathological and radiological) were primary endpoints.
Main Results:
- Four patients (27%) achieved a major pathological response, with PET-CT showing response in all.
- PD-L1 expression ≥10% correlated with major pathological response.
- Grade 2-3 treatment-related adverse events occurred in 33% of patients; postoperative morbidity was 7%, with 0% 30-day mortality.
Conclusions:
- Neoadjuvant pembrolizumab is a feasible and safe treatment option for patients with resectable NSCLC.
- The therapy demonstrated tolerable toxicity and did not compromise the ability to perform tumor resection.
- Early results suggest potential for significant antitumor activity in this patient population.
